family tools
choose a tool resource directory
find a practitioner parenting toolbox product safety media reviews family fun guide send an e-card family astrology

community features choose a feature birth stories find a Mothering friend live chat mothers' writing group teen voices

	a quiet place by peggy o'mara

Vaccinations: Why All The Fuss?
Issue 134
by Peggy O'Mara

Mothering has been publishing articles on vaccination for 27 years. In 1979, our first article on vaccines was intended for the early Mothering readership of natural-living pioneers who questioned medical interventions in general.

Newer generations question not only the general effects of vaccinations, but also specific vaccines and specific ingredients of vaccines. In 1982, for example, parents whose children were injured by the whole-cell pertussis vaccine formed the organization Dissatisfied Parents Together (DPT) and lobbied for passage of the National Childhood Vaccine Injury Act, which went into effect October 1, 1988. This act created the Vaccine Injury Compensation Program (VICP), and required vaccine providers to give benefit and risk information to parents before children are vaccinated, to keep written records of vaccine manufacturers' names and the lot numbers of each vaccination given, and to report adverse events following vaccination to the federal government through the Vaccine Adverse Events Reporting System (VAERS).

DPT became the National Vaccine Information Center in 1989, and the organization's continued advocacy for a safer pertussis vaccine led, in 1996, to the licensing in the US of the acellular pertussis vaccine, which has been in use in Japan since 1981. Fewer adverse events are associated with the acellular than with the whole-cell vaccine.

Two other vaccines began to be questioned in the 1990s: measles-mumps-rubella (MMR) and hepatitis B. The MMR vaccine, added to the vaccine schedule in 1979, is a live vaccine and does not contain a preservative. Research reported in 1998 by British physician Andrew Wakefield, and since confirmed by others, showed the presence of a persistent measles infection in the guts of some autistic children who had never had measles. It has been theorized that combining measles and mumps viruses in a single vaccine may cause gastrointestinal problems that could lead to autism.

In 1991, the Centers for Disease Control (CDC) recommended that all infants receive their first dose of the hepatitis B vaccine before being discharged from the hospital, even though the only newborns at risk are those born to mothers already infected with hepatitis B. Only 15 states require mandatory hepatitis B screening for all pregnant women, yet 35 states require that children have three full doses of hepatitis B before they can be admitted to daycare or begin school.

In 1998, France became the first country to stop requiring hepatitis B vaccination for schoolchildren. This followed reports that many French children were developing chronic arthritis and symptoms resembling multiple sclerosis following administration of the vaccine.

On May 18 and 19, 1999, the House Subcommittee on Criminal Justice, Drug Policy, and Human Resources held a hearing chaired by John Mica (R-FL), "Hepatitis B Vaccine: Helping or Hurting Public Policy." According to testimony by Jane Orient, MD, executive director of the Association of American Physicians and Surgeons, "Children younger than 14 are three times more likely to die or suffer adverse reactions after receiving hepatitis B vaccine than to catch the disease." An independent analysis confirmed that in 1996 there were 827 serious adverse events in children under 14 associated with hepatitis B reported to the VAERS. During that same period there were only 279 reported cases of hepatitis B in children under 14.

Following the hearing, the American Academy of Pediatrics (AAP) and the CDC suspended the hepatitis B vaccine for low-risk newborns. On July 9, 1999, a joint statement by the Public Health Service (PHS) and the AAP called for a rollback of the recommendation that all newborn infants receive the hepatitis B vaccine at birth, and for a delay in the vaccination of premature or underweight babies.

These concerns, however, are dwarfed by concerns about thimerosal, the mercury-based preservative used in all vaccines and biologics since the 1930s. The FDA Modernization Act of 1997 called for the Food and Drug Administration to review and assess the risk of all mercury-containing foods and drugs. In response, the FDA asked US vaccine manufacturers to provide information about the thimerosal content of their preparations.

Later that year, the Environmental Protection Agency (EPA) released the "Mercury Study Report to Congress," in which the agency set a reference dose of 0.1 microgram of mercury per kilogram of weight per day as the precautionary limit for mercury exposure. On July 17, 1999, the EPA notified vaccine experts that if infants younger than six months receive a number of vaccines containing thimerosal during a single visit to the doctor, their mercury levels might exceed the EPA's precautionary limit for mercury exposure. The FDA requested that vaccine manufacturers voluntarily phase in a replacement for thimerosal.

That same year, the AAP and the PHS also called for the removal of thimerosal from childhood vaccines, something that had been done in Denmark seven years earlier. However, no recall was ever issued in the US, and no deadline was set for the removal of thimerosal.

While most childhood vaccines today are available with "only" trace amounts of thimerosal, the AAP no longer cautions about the use of thimerosal in vaccines, and does not suggest thimerosal-free vaccines for infants and pregnant women when recommending the flu vaccine. The media downplay and often dismiss concerns about vaccines, particularly about vaccines containing thimerosal. The prestigious Columbia Journalism Review acknowledged this in October 2005, and concluded that it "seems too soon for the press to shut the door on the debate."

Choosing whether or not to have a child vaccinated, especially in light of the politics of vaccines, must be an independent decision. It should not be coerced, but be the product of true informed consent. Few people even know that they have a choice regarding vaccinations, much less know what informed consent really is.

In fact, all 50 states grant medical exemptions to vaccination. All states except Mississippi and West Virginia have religious exemptions, many of which are written broadly. An increasing number of states also have philosophical exemptions: Arizona, California, Colorado, Idaho, Louisiana, Maine, Michigan, Minnesota, New Mexico, Ohio, Oklahoma, Texas, Utah, Vermont, Washington, and Wisconsin. More recently, California, Delaware, Illinois, Iowa, Missouri, and New York have banned the use of thimerosal in vaccines, and bans in many more states are in process. Representatives David Weldon (R-FL) and Carolyn Maloney (D-NY) have introduced a national bill to ban thimerosal in all US vaccines.

Some parents want to comply with the entire vaccination schedule; others want no vaccinations at all. Some parents want certain vaccines but not others. And some want to delay the vaccines until their baby is older. These parents will all need written exemptions from their state health departments, even though exemptions are technically designed for those who choose to forgo vaccines altogether.

While vaccine advocates debate the wisdom of conscientious choice regarding vaccines, ethicists insist that it is integral to the mandatory vaccine program, and the legal system supports it as well. In fact, the US has a 100-year jurisprudential tradition of informed consent. But what is informed consent?

Medical associations themselves have set standards for informed consent. More than 30 years ago, the American College of Obstetricians and Gynecologists (ACOG) recognized the patient's right to informed consent. In their 1974 Standards for Obstetric-Gynecologic Services, informed consent is defined as: 1) The patient is informed about the processes contemplated by the physician as treatment, including whether the treatment is new or unusual. 2) The patient is informed of the risks and hazards of the treatment. 3) The patient is informed of the chances of recovery after treatment. 4) The patient is informed of the feasibility of alternative methods of treatment.

The physician is not justified in failing to inform the patient because the patient might decline the recommended treatment. In fact, the right to decline is the fundamental right specifically protected by the doctrine of informed consent. But parents are seldom offered enough information about vaccines to sufficiently inform any consent they might give. In fact, new parents are kicked out of medical practices for even asking questions about vaccinations.

It is thimerosal, however, which is at the heart of the current vaccine controversy. Thousands of parents have claimed that their previously perfectly normal children regressed to autism after receiving vaccinations. Blood tests show that these children have elevated levels of mercury in their bloodstreams that remain otherwise unexplained.

Many of these parents are suing the federal government and the vaccine manufacturers. Normally in such cases, the parents' doctor would notify the Vaccine Adverse Events Registration System (VAERS) of an adverse event associated with a vaccine. The parents would file a claim with the Vaccine Injury Compensation Program (VICP), and their claim would be heard. In order for a vaccine-adverse event to be compensated by the VICP, however, it must be listed on the Vaccine Injury Table, which includes only specific vaccines. Autism is not listed on the table, and is not recognized by the VICP as an injury for which the government compensates. Because the cost of taking care of an autistic child is $3 to $5 million over the child's lifetime, parents see the courts as their only recourse.

Autism is not listed on the Vaccine Injury Table because the Institute of Medicine (IOM) has failed to find evidence that thimerosal in vaccines causes autism. They have said that while the causal link is "plausible," the evidence does not warrant further investigation. The IOM has been widely criticized for this conclusion because they considered only epidemiological evidence, while controlled studies offer ample evidence of a possible association. In fact, two studies of the CDC's own Vaccine Safety Datalink (VSD) show that thimerosal may cause autism.

Mass vaccines are, in many ways, a recent experiment. They began in the 1950s and were heralded by a horrific event. In 1955, 70,000 people got polio within days of being vaccinated; 200 were paralyzed and 10 died. Cutter Laboratories had failed to kill the polio in the vaccine.

According to Paul Offit, author of a new book, The Cutter Incident, this event was the beginning of modern liability awards. Offit bemoans the fact that vaccine manufacturers can be found liable even if they are not guilty of malice. While his point is well taken, the alternative of a government compensation program, the VICP, has thus far not been successful for parents of vaccine-injured children. The VICP was intended to be an easy, no-fault way for parents to receive compensation for vaccine injuries. In fact, the process of compensation is costly and denies most petitioners.

Of the 5,652 cases that have so far been concluded, only 32 percent of petitioners to the VICP have been awarded compensation. The process takes at least two years, and legal fees can run into the hundreds of thousands of dollars. Since its inception, the VICP has received a total of 8,237 vaccine-injury claims, of which 3,854 have been dismissed, 2,585 are pending, and 1,798 have been granted awards, for a total compensation of $1.4 billion. Of the 8,237 claims filed, 4,261 were for vaccine injuries that occurred before 1988"hprimarily from the whole-cell pertussis component of the DPT vaccine. The average compensation is $778,643. Currently, more than $1.8 billion of the VICP's trust fund remains unused.

Choice is important for many reasons. First, informed consent is a doctrine of US health policy and US jurisprudence. Second, we live in a country in which health care is a business, which makes us simultaneously patients and clients. Third, it has been parent advocacy that has resulted in safer vaccines. Most important, however, is that you choose in order to live peacefully with the outcome of your choice, no matter what it is. Only when your choice is not coerced can you live with the inevitable regrets that come when things do not turn out as you'd hoped they would.